Events

Alerte De Sécurité sur Synchron Systems Salicylate Reagent

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Beckman Coulter.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-06-29
  • Date de publication de l'événement
    2017-06-29
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170629a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: beckman coulter synchron systems salicylate reagent medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its synchron systems salicylate reagent (saly). all lots of saly with reference number 378194 are affected. the manufacturer has identified temozolomide, an oral antineoplastic drug used to treat certain types of brain cancers, as a potential source of interference with synchron salicylate reagent. according to the manufacturer, temozolomide concentrations of 40 mg/l or greater may cause a negative bias in salicylate test results of up to -22%. the half-life of temozolomide is approximately 1.8 hours, with the active half-life of the metabolite being slightly longer. the probability of an erroneous patient result will be dependent upon the times of administration and dosages of both drugs, salicylate and temozolomide. longer intervals of time between administration of the drugs and the testing will reduce the probability and severity of harm. lower doses of either drug will also reduce the severity of harm. the worst case scenario only occurs if a patient that is overdosed on salicylates is tested within a short period of time after receiving a high dose of temozolomide. information regarding interference with this drug will be added to the saly chemistry information sheet (cis). the cis will be updated on the beckman coulter website's technical documents webpage. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 june 2017.

Device

Synchron Systems Salicylate Reagent
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter Synchron Systems Salicylate Reagent
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter